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pinpoint gt introducer needle
C.R. Bard
Summary: The Pinpoint GT Introducer Needle is a medical device used primarily in vascular procedures to introduce embolization coils. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K162769 ↗
Decision Date
November 4, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinpoint GT Introducer Needle was cleared through the FDA 510(k) pathway on November 4, 2016. It is manufactured by C.R. Bard and classified as a Class 2 device under product code DYB.
What It Is
The Pinpoint GT Introducer Needle is a specialized needle designed to facilitate the introduction of embolization coils into the vascular system. It features a sharp, precise tip that allows for easy vascular access. This device is typically used in minimally invasive procedures, providing a conduit for other devices to be introduced into the vasculature.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the embolization of aneurysms or other vascular abnormalities. The introducer needle is essential for creating a pathway for embolization coils, which are used to occlude blood vessels in patients with conditions such as arteriovenous malformations or aneurysms.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring the introduction of embolization coils. It is suitable for patients needing vascular occlusion to treat conditions like aneurysms or vascular malformations.
Practical Considerations
The Pinpoint GT Introducer Needle comes in various sizes to accommodate different vascular access needs. It is compatible with standard embolization coils and should be used with appropriate imaging guidance to ensure accurate placement. Clinicians should be trained in vascular access techniques to optimize outcomes.
Frequently Asked Questions
What is the Pinpoint GT Introducer Needle used for?
It is used to introduce embolization coils into the vascular system during procedures to treat aneurysms or vascular malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in minimally invasive vascular procedures.
What are the FDA-cleared indications?
The device is indicated for the introduction of embolization coils in procedures requiring vascular occlusion, such as treating aneurysms or vascular malformations.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.